Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2017 Publisher: AstraZeneca UK Limited, Horizon Place, 600 Capability Green, Luton, Bedfordshire, LU1 3LU, United Kingdom
Nexium 10 mg gastro-resistant granules for oral suspension, sachet.
| Pharmaceutical Form |
|---|
|
Gastro-resistant granules for oral suspension, sachet. Pale yellow fine granules. Brownish granules may be visible. |
Each sachet contains: 10 mg esomeprazole (as magnesium trihydrate).
Excipients with known effect: Each sachet contains 6.8 mg sucrose and 2.8 g glucose.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Esomeprazole |
Esomeprazole is the S-isomer of omeprazole and reduces gastric acid secretion through a specific targeted mechanism of action. Esomeprazole is a weak base and is concentrated and converted to the active form in the highly acidic environment of the secretory canaliculi of the parietal cell, where it inhibits the enzyme H+ K+ -ATPase – the acid pump and inhibits both basal and stimulated acid secretion. |
| List of Excipients |
|---|
|
Esomeprazole granules: Glycerol monostearate 40-55 Excipient granules: Citric acid anhydrous (for pH adjustment) |
Carton containing 28 or 30 sachets. Not all pack sizes may be marketed.
Sachets (containing granules): Laminate consisting of three layers: polyethylene terephthalate (PET), aluminium, low density polyethylene (LDPE) which protects the granules against moisture.
AstraZeneca UK Limited, Horizon Place, 600 Capability Green, Luton, Bedfordshire, LU1 3LU, United Kingdom
PL 17901/0253
Date of first authorisation: 28 July 2008
Date of latest renewal: 10 March 2010
| Drug | Countries | |
|---|---|---|
| NEXIUM | Austria, Australia, Brazil, Canada, Cyprus, Germany, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Malta, Mexico, Nigeria, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States |
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